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Biochemical Evaluation of Periodontal Effects of Orthodontic Treatment with Aligners

Biochemical Evaluation of the Effect of Orthodontic Treatment with Aligner on Periodontal Parameters and OPG and RANKL Salivary Values

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06646705
Enrollment
25
Registered
2024-10-17
Start date
2023-04-06
Completion date
2024-12-30
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aligner Treatment

Brief summary

The aim of this study was to determine the effect of orthodontic treatment with aligner on changes in osteoprotegerin (OPG) and receptor activator of NF-κB ligand (RANKL) levels in saliva samples and to investigate the possible relationship between periodontal clinical parameters. Materials and Methods: A total of 25 (n=25) saliva samples were taken from systemically healthy non-smoking individuals who were planned to receive orthodontic treatment with aligner before treatment. Whole mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded and repeated at 1 and 3 months. Enzyme-linked immunosorbent assay (ELISA) was used to determine OPG and RANKL levels in biological samples.

Interventions

DIAGNOSTIC_TESTSaliva obtaining

The patient was asked to sit upright and tilt his/her head forward to collect saliva samples. İn this way, unstimulated saliva was allowed to accumulate in the floor of the mouth. The accumulated saliva was collected in a sterile container. It was then transferred to a propylene tube. The tubes were centrifuged and the clear part at the top of the tube was taken with a sterile syringe and transferred to a different propylene tube with 0.5 ml in each tube. Tubes were stored at -80ºC until the day of analysis.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.) * Must receive orthodontic treatment with aligners and must have accepted the treatment * Non-smoker * No medication for continuous use * Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months. * Not in pregnancy or lactation period.

Exclusion criteria

* Any oral or systemic disease * Regularly using a systemic medication * During pregnancy or lactation * Received periodontal treatment within the last 6 months. * Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months * Smokers are not included in the study

Design outcomes

Primary

MeasureTime frameDescription
The total amount of OPG in saliva24 hours after taking the clinical measurementsThe total amount of osteoprotegerin in saliva

Secondary

MeasureTime frameDescription
The total amount of RANKL in saliva24 hours after taking the clinical measurementsThe total amount of receptor activator of NF-κB ligand in saliva

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026